Assist in QC instrument and equipment management, such as C-type instruments including HPLC, GC, IC, and LC-MS, as well as B-type instruments like pH meters, balances, and color meters.
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Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience
Detect non-compliance with cGxP and cGDP requirements and provide guidance on GDP corrections
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Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
Works closely with global/local QC stakeholders to develop and endorse the following: -Analytical transfer plan and Validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global QC networks on test method innovation/ evaluation to support the project team in facility design / modification, specifically for QC operations.
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